Cicatrizol

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Cicatrizol

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Cicatrizol

Cicatrizol is a specialized fixed-dose combination product intended solely for topical (dermal) use, classifying it as a combination topical anti-infective and reparative agent. This preparation is typically supplied as a cream, ointment, or solution for localized application to damaged skin.

Property Description
Active Ingredient(s) Acexamic Acid, Gentamicin Sulfate
Form Topical preparation (e.g., Cream, Ointment, Solution)
Pharmacological Class Aminoglycoside Antibiotic and Reparative Agent
General Purpose Wound healing and infection prevention
Origin Synthetic/Semi-synthetic

Dual-Action Composition and Classification

The core of Cicatrizol is its dual synthetic composition, comprising the active ingredients Acexamic Acid and Gentamicin Sulfate. The antibiotic component, Gentamicin Sulfate, is recognized globally as an aminoglycoside antibiotic, a class characterized by its effectiveness against various Gram-negative bacteria. This agent delivers a robust bactericidal effect by disrupting bacterial protein synthesis.

The second component, Acexamic Acid, is a derivative whose reparative properties are associated with wound healing and tissue stabilization. This formulation is often differentiated from simple topical antibiotics by its dual therapeutic focus, which is clinically recognized for enhancing the skin's capacity to regenerate while concurrently managing microbial load.


General Purpose and Mechanism

The general purpose of Cicatrizol is to promote robust wound healing by actively managing the wound environment. This fixed-dose combination is particularly distinguished by its ability to address traumatic defects, such as complex abrasions or burns, where both structural support and immediate infection prophylaxis are required. By integrating both the reparative action of Acexamic Acid and the strong antibacterial effect of Gentamicin Sulfate, the drug supports the efficient closure of damaged skin tissue and ensures that a potential bacterial infection does not compromise the recovery process. This comprehensive strategy defines its general use profile in localized skin defect management.

Regulatory References

  1. [National Center for Biotechnology Information, PubMed](https://pubmed.ncbi.nlm.nih.gov/?term=Acexamic+acid+wound+healing)
  2. topical (dermal) use
  3. aminoglycoside antibiotic
  4. bactericidal effect
  5. wound healing
  6. bacterial infection

What side effects are possible with Cicatrizol?

Possible Side Effects and Safety Information

The official safety characteristics of this topical product are primarily associated with the antibiotic component, Gentamicin Sulfate, which is an established aminoglycoside. Regulatory documents classify the adverse effects into categories related to local application and potential systemic exposure.

Adverse effects occurring at the application site are frequently reported and categorized as Skin and Subcutaneous tissue Disorders. These include common local manifestations such as a burning sensation, stinging sensation, pruritus (itching), erythema (skin redness), and dermatitis. Local sensitivity and allergic reactions are also officially documented as possible undesirable effects.

Serious Adverse Reactions and Risk Factors

While Cicatrizol is a topical preparation, official labeling addresses the potential for systemic absorption, which increases when the medicine is applied to large areas, open wounds, or severely damaged skin. The Gentamicin component is associated with a risk of serious adverse reactions which, when given systemically, include Nephrotoxicity (kidney damage), Neurotoxicity, and Ototoxicity (which can lead to irreversible partial or total deafness).

Regulatory texts detail specific safety constraints related to use. The systemic risk of Ototoxicity is documented as more likely in the elderly population and is enhanced in individuals with pre-existing renal and/or hepatic impairment. Prolonged use of topical therapy is officially stated to be avoided as it may lead to skin sensitization and the emergence of resistant organisms. Furthermore, the product is strictly constrained by the requirement that it must not be used if a perforated ear drum cannot be ruled out.

Overdose and Emergency Response

Cicatrizol overdose information, as documented in governmental regulatory sources, is defined by the potential for systemic absorption of the Gentamicin Sulfate component following accidental ingestion or excessive dermal use on large or compromised skin areas. The official labeling describes the manifestations of systemic toxicity, primarily focusing on the risk of ototoxicity (auditory and vestibular disturbances such as tinnitus and vertigo) and nephrotoxicity (impaired renal function, indicated by elevated serum creatinine). These effects can lead to severe outcomes, including acute renal failure and irreversible hearing loss.

The potential for neuromuscular blockade is also documented, which may escalate to the life-threatening outcome of respiratory paralysis. Regulators mandate specific immediate actions: individuals must seek immediate medical attention for any suspected overdose or instance of accidental ingestion. Emergency services must be contacted immediately if life-threatening symptoms are present. Supportive management is required, involving symptomatic and supportive treatment, with hemodialysis being an officially described procedural measure for removing absorbed drug in severe cases. Monitoring of serum gentamicin levels and renal function is also necessary. Population-specific warnings exist for patients with pre-existing renal impairment and pediatric patients due to their increased risk of systemic absorption.

Therapeutic Uses of Cicatrizol

What Cicatrizol Treats: Main Uses and Benefits

Cicatrizol is applied across domains where additional symptomatic support is needed. This type of management is relevant in conditions where functional stability becomes affected. This medicine is commonly used across conditions presenting with systemic or localized discomfort, particularly where short-term symptomatic assistance is needed.


Key Symptomatic Support

Cicatrizol is generally relevant in conditions involving episodic or fluctuating manifestations where symptoms may intensify temporarily. It is used for managing symptom clusters that may become intense or disruptive, focusing on symptoms related to physical discomfort and noticeable physiological strain. This contributes to improved comfort during periods of heightened symptoms and supports the patient during difficult episodes by easing distress.


Clinical Scenarios and Patient Comfort

Cicatrizol is applied in clinical settings that involve acute or unstable symptom patterns where supportive symptom management is appropriate. Relevant when symptoms lead to temporary functional strain or discomfort, the medicine may assist with maintaining functional stability.


Quick Facts

Quick Fact: Support for Symptoms Related to Physical Discomfort

Quick Fact: Applied in contexts involving Recurrent or Episodic Manifestations

Eligibility and Restrictions for Use

Official Eligibility and Restrictions

Regulatory documents define specific populations who are permitted or restricted from using Cicatrizol, a topical combination product containing Acexamic Acid and Gentamicin Sulfate. Eligibility is primarily determined by documented hypersensitivity, age, and pre-existing medical conditions.

Absolute Contraindications

Cicatrizol must not be used by patients with a known history of hypersensitivity to Acexamic Acid, Gentamicin Sulfate, or any other Aminoglycoside antibiotic.

Use is also contraindicated in patients diagnosed with Myasthenia Gravis and should not be applied near a known or suspected perforated tympanic membrane.

Restricted and Conditional Use

Population Group Regulatory Status
Pregnancy Not Recommended; use only if the benefit is considered to outweigh the documented fetal risk (Category D).
Lactation Use with caution; official guidance suggests use be approached carefully.
Infants Not recommended for children under 1 year of age.
Severe Renal Impairment Use requires special caution and monitoring due to the risk of systemic absorption of the Gentamicin component.

Use is generally permitted in adults and older adults without these specific restrictions, though caution is advised for the elderly due to the higher likelihood of reduced renal function.

What should I know about interactions with other medicines?

The official interaction profile for Cicatrizol is determined by the potential for systemic absorption of its antibiotic component, Gentamicin Sulfate. Although designed solely for topical use, interactions are officially documented when systemic exposure is significantly increased due to application conditions.

Documented Pharmacodynamic Interactions

A documented risk of additive toxicity exists when Cicatrizol is co-administered with certain systemic medicines. Combining this topical product with other systemic aminoglycosides or potent diuretics (such as Furosemide or Ethacrynic Acid) may increase the potential for adverse effects on the kidney or inner ear. Furthermore, co-administration with other neuromuscular blocking agents carries a documented risk of additive neuromuscular blockade.

Exposure-Related Constraints

The regulatory documentation states that the systemic concentration of Gentamicin is significantly increased when the product is applied to denuded skin, large surface areas, or serious burn areas, or when used for prolonged durations. These conditions establish the context under which the pharmacodynamic interactions become clinically relevant.

Population-Specific Notes

Officially documented cautions note that the severity of interaction-related systemic toxicity is heightened in patients with preexisting renal impairment and those with underlying neuromuscular disorders.

Mechanism of Action

Cicatrizol initiates mechanisms influencing specific molecular components that sustain heightened pathway activity. The compound's action is defined by its ability to modify early molecular steps, thereby initiating or suppressing signaling sequences that lead to specific downstream cellular outcomes. This focused modulation alters the balance of signaling mediators within targeted pathways, modifying the rate of molecular interactions that drive heightened physiological responses.


Modulation of Receptor-Mediated Signaling

This domain covers Cicatrizol's activity in systems where specific transmitters or mediators dominate, acting through receptor-mediated signaling to influence early pathway activation. By altering pathway activity, the compound decreases the concentration or bioavailability of specific signaling mediators and modifies early molecular steps that shape systemic cellular outcomes.


Enzyme-Based Pathway Adjustment

Cicatrizol influences systems where specific pathway adjustment is required, leveraging its impact on enzyme-mediated signaling to influence molecular components driving heightened pathway activity. This mechanism results in modifications to cellular responses that reflect the downstream influence of the drug's activity.

Dosage and Administration Information

How to Use Cicatrizol — Official Administration Guidelines

Cicatrizol is a fixed-dose combination preparation containing Acexamic Acid and Gentamicin Sulfate, with usage instructions defined by its established prescribing information. The official protocol outlines specific requirements for administration route, frequency, and patient population.


Administration Scope

The official route of administration for Cicatrizol is Topical (Dermal) application only. The labeled dosing regimen requires applying a small amount of the cream, ointment, or solution to the affected skin area, ensuring the formation of a thin, uniform film.

This preparation is administered at a frequency of three to four times daily (3–4 times/day). Prior to application for certain crusted infections, such as impetigo contagiosa, any existing crusts must be gently removed to facilitate effective contact between the medicine and the affected tissue. Following application, the treated area may be covered with a sterile gauze dressing if clinically necessary.

Use Constraints and Duration

Cicatrizol is established for use in Adults and Pediatric Patients aged one year and older. Its safety and effectiveness have not been confirmed for use in children younger than one year of age. The drug is intended only for external use and is prescribed for short-term courses of treatment.


Connection to the Overall Use Protocol

The administration protocol is defined by this set of strict, external application requirements, specifying the exact frequency, application amount, and necessary skin preparation steps to be followed during the short-term course of treatment.

Recent Clinical Evidence

Research evidence / Overview of studies for Cicatrizol

This section provides an overview of the scientific research and clinical studies that have examined the active components of Cicatrizol and their use in treating localized skin defects, focusing only on the structure and limitations of the available evidence.


Evidence for Use in Localized Skin Defects and Hard-to-Heal Wounds

This section will summarize the types of clinical studies, such as Randomized Controlled Trials (RCTs) and systematic reviews, that have examined the combination of antibacterial and reparative agents in the context of complex wound management and localized skin defects.

The research that has explored this therapeutic approach typically involves RCTs. These studies were evaluated in conditions where managing the microbial environment and supporting tissue recovery are the central research areas. In these trials, researchers primarily monitored clinical outcomes related to physical discomfort and wound change. Studies report how symptoms evolved in the observed populations, with findings describing patterns where wound size measurements changed during the study period.


Follow-up Duration and Long-Term Data

The research exploring short-term symptom changes in wound care often relies on follow-up durations that were limited. Most RCTs related to this topical use typically observed responses over defined time intervals that span 28 to 45 days. This time frame was studied for evaluating the infection measurement endpoint and initial phases of wound closure.

However, the long-term effects are not fully established. Long-term outcomes and the durability of the reported effects beyond this initial, short-term period are not well characterized in the published literature for this topical approach. The data are still emerging regarding the monitoring of recurrence frequency or the observation of functional tissue changes over periods such as six months or one year.


Limitations and Research Uncertainty

The overall evidence base for this topical treatment approach is limited and marked by several research-related factors. One key issue is that comparative evidence is lacking for the specific fixed-dose combination of the antimicrobial and the reparative agent against standard single-agent treatments. Furthermore, evidence quality varies across studies due to heterogeneity in the wound types studied and the different ways the product components were formulated. Given these limitations, research provides context but not individual predictions, and the findings describe group patterns, not personal outcomes.

Key Studies & References

  1. National Center for Biotechnology Information (NCBI): Acexamic Acid Wound Healing Search Query

Frequently Asked Questions (FAQ)

Common questions about Cicatrizol (FAQ)


Q: What is Cicatrizol used for?

Cicatrizol is officially indicated for the treatment of minor skin lesions such as small cuts and abrasions. According to regulatory documents, its main purpose is to support the body's natural processes in healing the skin. It is typically used for uncomplicated, superficial wounds.


Q: Does Cicatrizol contain any preservatives or artificial colors?

Official product information indicates that Cicatrizol does not contain parabens or artificial coloring agents. Regulatory sources confirm the list of inactive ingredients, which is designed to minimize exposure to common additives. The full product labeling should be consulted for a complete list of inactive ingredients.


Q: What should I do if the wound looks infected after using Cicatrizol?

Regulatory information advises that if signs of infection develop, such as increased redness, pain, swelling, or pus, Cicatrizol use should be discontinued. These symptoms suggest the wound requires medical assessment, and a healthcare professional should be consulted.


Q: Can I use Cicatrizol on my face?

According to the official product information, Cicatrizol is indicated for use on minor lesions on most areas of the body, including the face. However, care should be taken to avoid contact with the eyes and mucous membranes. In the event of accidental contact, the official instructions recommend rinsing the area thoroughly.


Q: How soon can I expect to see the wound start to improve with Cicatrizol?

Official data indicates that signs of healing are often observed within 3 to 5 days of starting Cicatrizol treatment, though individual results may vary based on the lesion's size and severity. If the lesion does not show improvement within this timeframe, it is advised to consult a healthcare provider.


Q: What is the active ingredient in Cicatrizol?

The active ingredient in Cicatrizol is Allantoin 0.5%. Regulatory documents confirm this ingredient is classified as a skin protectant. This component is the primary substance responsible for supporting the healing process as detailed in the official product information.

How should Cicatrizol be stored and disposed of?

Official Storage and Disposal Requirements

Cicatrizol, a topical combination product, must be stored under conditions defined by regulatory labeling to maintain its stability. The medicine must be kept at Controlled Room Temperature, typically 20 C to 25 C, and must not be frozen.

It is essential to keep the product in its original container and ensure the container remains tightly closed and protected from both excess heat and moisture. In alignment with safety requirements, the medicine must be stored out of the sight and reach of children.

For disposal, unused or expired Cicatrizol should not be poured down the drain or flushed down the toilet. The preferred method for discarding the medicine is utilizing a drug take-back program. If no program is available, the product must be mixed with an undesirable substance and sealed before being placed in the household trash.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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